The Desarda and Lichtenstein Techniques in Inguinal Hernia Treatment.

Hernia, Inguinal Clinical Trial

— DESLICH  

Official title:

The Desarda and Lichtenstein Techniques in Primary Hernia Treatment in Adult Males: Randomised, Multicenter, Blinded Study.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01237470
• Other study ID #: Nicolaus Copernicus University
• Status: Terminated
• Phase: N/A
• First received: November 8, 2010
• Last updated: November 8, 2010
• Start date: January 2005
• Est. completion date: June 2009

Study information

• Verified date: July 2010
• Source: Nicolaus Copernicus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Contemporary treatment of inguinal hernia is generally based on surgical methods with the use of synthetic meshes. The implanted meshes however have some disadvantages: they increase the risk of infection, tend to sustain inflammation process, can generate chronic pain and fertility disorders, can move from the initial implantation site, increase costs of treatment etc. The research to find any new hernioplasty without the use of meshes is still going on.

Desarda in 2002 year published his own results over hernia treatment with the use of external oblique aponeurosis. These results were comparable with the effects of Lichtenstein technique.

The initial assessment done in our own department revealed good clinical results after hernia treatment with Desarda's method.

To make appropriate and objective clinical assessment of the Desarda's technique for primary inguinal hernia treatment the randomized multicentre double blinded clinical trial (RCT) was projected and conducted. Finally, 105 patients were included in the Desarda group and 103 in the Lichtenstein group. Personal clinical follow up was made up to 3 years after operation.

Generally no statistically significant differences were found between these groups. The only difference was higher rate of seroma after Lichtenstein technique and different pain perception in both groups. To the summary it is clear that Desarda technique is quite attractive and good proposition for operative hernia treatment without mesh. The RCT was done with the use of SharePoint Portal Server (Microsoft) which seems to be appropriate for clinical trials.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2009
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• primary inguinal hernia

• male adults

• signed informed consent

• god condition of external oblique aponeurosis (assessed during the operation)

Exclusion Criteria:

• age < 18

• recurrent hernia

• incarcerated hernia

• diagnosed mental disorder

• manual reduction of hernia on inpatient

• infection at groin area

• wound or scar at the groin

• no consent

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal

Intervention

Procedure:
• Desarda technique
no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
• Lichtenstein technique
hernioplasty with the usage of plain polypropylene mesh

Locations

Country	Name	City	State
Poland	Department of General and Endocrine Surgery, Collegium Medicum, Nicolaus Copernicus University	Bydgoszcz

Sponsors (1)

Lead Sponsor	Collaborator
Nicolaus Copernicus University

Country where clinical trial is conducted

Poland, 

References & Publications (2)

Desarda MP. Inguinal herniorrhaphy with an undetached strip of external oblique aponeurosis: a new approach used in 400 patients. Eur J Surg. 2001 Jun;167(6):443-8. — View Citation

Desarda MP. Surgical physiology of inguinal hernia repair--a study of 200 cases. BMC Surg. 2003 Apr 16;3:2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence	hernia recurrence after surgical treatement	3 years
Primary	chronic pain	persistent chronic pain (lasting longer then 6 months)	6 months
Secondary	surgical complications	edema, hematoma, ecchymosis, infaction of the wound	3 years